Stent loading tool and method for use thereof

ABSTRACT

A loading tool for withdrawing, crimping, and loading a stent-mounted valve into a delivery catheter, and for pushing the stent-mounted valve from the delivery catheter into a native heart valve orifice. The loading tool comprises at least one connector adapted for being removably connected to the stent of the stent-mounted valve. A crimping tool having a generally converging shape is adapted for use with the loading tool. Following connection of the loading tool to the stent-mounted valve, the loading tool operates to allow the stent-mounted valve to be drawn through the crimping tool, and loaded, in a crimped state, into a delivery catheter. Also disclosed is a kit of the various components for effecting the delivery of the stent-mounted valve and a method for withdrawing, crimping, and loading a stent-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure.

FIELD OF THE INVENTION

The present invention of a device and methods generally relates to thefield of cardiac medical technology. In particular, the device relatesto a loading tool that may be used in crimping, loading, and delivery astent-mounted valve or other expandable prosthetic device.

BACKGROUND OF THE INVENTION

Stents are bioprosthetic devices that are typically used forcounteracting restenosis, or the repeated narrowing of a blood vessel.Stents may also be used, for example, as shown in U.S. PatentApplication 2006/0149360 to Schwammenthal, et al, as a component of astent-mounted heart valve with mounted leaflets. The stent mounted valveimplant described there includes clamping fingers that secure itsposition at a native valve orifice of the heart.

Such an implant is delivered to its site in the heart using a catheterassembly. To pass through the catheter, the prosthetic valve must becollapsed to a smaller profile. However, since the stent-mountedprosthetic valve has leaflets of pericardium material, it cannot bedelivered to the hospital or medical facility in a collapsed orcompressed state. Rather, the step of collapsing the implant for passagethrough the delivery device must be carried out shortly before theimplantation procedure. Consequently, the valve, in an open state, isdelivered to the user in a container and that container typicallycontains a sterile, preservative medium such as glutaraldehyde.

Thus, prior to the implantation procedure, the stent-mounted valve mustfirst be manually removed from the storage medium package, collapsed(perhaps by crimping), and then loaded into the delivery catheter inthat crimped state.

Several cautions are to be observed prior to and during the step ofloading the stent-mounted prosthetic valve. Since the material making upthe stent is easily deformed or damaged, the stent must be handled withgreat care. Secondly, the stent must be crimped or otherwise collapsedto the smaller profile so that it fits properly inside of the catheterdelivery tube. The step of collapsing the stent is a delicate processand, if not performed properly, may cause delay the implantationprocedure or may entail excessive handling of the stent or even damageto the valve. Removal of the stent from the glutaraldehyde liquid mediumin the storage and delivery container by surgically-gloved surgicalpersonnel may be awkward.

Specialized tools may be used to minimize the risks associated withpreparing the stent-mounted valve for the step of implanting theprosthetic valve in the heart.

U.S. Patent Application No. 2004/0186563, to Lobbi, discloses a heartvalve that is loaded into the delivery catheter using a specializedtool. The valve is crimped or collapsed to a smaller profile by pullingit through a conical-shaped region of the specialized tool. One or morefilaments threaded through the valve to allow such pulling andconsequent crimping of the valve. A drawback to this procedure is thatthe step of threading the filaments through the valve can be a tediousand time-consuming process. Also, since the filaments have no purposeafter the crimping step, they must be removed from the implant prior tothe delivery procedure. Removal of the filaments may cause damage to thevalve and may even partially undo the crimping step.

U.S. Patent Application No. 2003/0225445 to Derus et al., describes aloading device having a conical-shaped region for facilitating thecollapse of a stent. As with the Lobbi procedure, a filament or the likeis used to pull the stent through the loading device to collapse it.

Other devices for transferring a stent from a storage container to adelivery tool are described in U.S. Pat. No. 6,090,035 to Campbell, U.S.Pat. No. 5,693,066 to Rupp et al., U.S. Pat. No. 6,123,720 to Andersonat al., and European Patents WO 98/22044 and WO 97/09946, both toBorghi.

None of these patents or patent applications show the device andprocedures described further hereinbelow, nor do they satisfactorilysolve the problems which have been described above relating to transferof the valve from a storage device, in which the valve is in an expandedstate, to the delivery tool, in which the valve is in a substantiallycompressed state.

There is thus a need for a tool that allows for transfer of the valve orother prosthetic device from the storage container to the catheterdelivery tube, in a relatively simple manner that requires only minimalhandling.

SUMMARY OF THE INVENTION

Accordingly, it is a broad object of the present invention to overcomethe above-mentioned disadvantages and limitations of the prior art andprovide a loading tool suitable for extracting a stent-mounted valvefrom its packaging, crimping that stent-mounted valve into a profilesuitable for introduction into a catheter delivery tube, and loadingthat stent mounted valve into a catheter delivery tube in a simple andreliable manner.

The described loading and delivery tool may be configured to become apart of the delivery system once it is loaded into a catheter deliverytube. Specifically, the loading tool may join to and be considered tobecome a part of an inner shaft of the catheter delivery tube, and,together with the inner shaft of the catheter, cooperate to push thestent-mounted valve outward from the catheter delivery tube once theappropriate location in the heart is reached. This functionality is dueto the structure (and consequent rigidity) of the loading tool. Thefilaments used in the crimping step of the procedures found in the Lobbiand Derus et al published applications must be removed prior to thetranscatheter procedure. As noted above, the filaments serve no functionduring the actual implantation of the stent.

The described loading tool may be used for withdrawing, crimping, andloading a stent-mounted valve into a catheter delivery tube, and furtherfor facilitating pushing of the stent-mounted valve from the catheterdelivery tube into a native heart valve orifice.

The loading tool may be configured to connect to and to be controllablybe disconnected from the stent component of the stoat-mounted valve. Inone such variation, the loading tool may comprise one or more connectorsadapted for being removably connected to the stent of the stent-mountedvalve.

The connector or connection section of the loading tool may, forinstance, comprise one or more prongs. For instance, the loading toolmay comprise three prongs. Where the connector comprises one or moreprongs, each prong may be characterized as having a substantially rigidportion and having a less rigid hinge region. Alternatively, each prongarm may be configured so that it flexes along its length. In eithercase, the flexibility of the prong allows the loading tool to becomepart of the delivery system during the transcatheter valve placementprocedure. The distal end of each prong is configured in such a way thatit may be attached to the stent-mounted valve via the stent component.In turn, the stent may include sites, portions, or members to bepositioned in such a way to cooperate with, and thereby be attached to,the connector or connecting section of the loading tool. In certaininstances, where the design of the stent and the connector permits, thestent may have at least three connecting members positioned around itsperiphery for facilitating attachment to three cooperating prongs of theloading tool.

Where prong are used as connectors to the stent, the prongs may have avariety of configurations meeting the goal of removable and controllableattachment to and separation from the stet. In one variation, each prongis formed with a radial outwardly facing notch at its distal end whichcooperatively engages a conforming connector of the stent-mounted valve.In usage, the operator places the ends of the prong over the end of thestent and compresses the prongs on the loading tool to move the notchedtips of the prongs and to align each of them with a correspondingconnector on the stent. The user then releases the prongs such that eachindividual prong becomes engaged, with a single stent connecting member.

The prongs may have notches or openings that face outwardly or that facetowards the end of the tool. In each instance, suitable interferingmembers would be employed to allow controllable attachment of the stentto the loading tool and subsequent release of the stent from the loadingtool.

The loading tool may be pre-mounted onto the stent-mounted valve andprovided in packaging together with a crimping tool. The crimping toolmay have a generally converging-shape allowing the user to compress thestent-mounted valve just prior to introduction into the deliverycatheter by pulling it from the packaging. This combination may beprovided as a kit, perhaps sterilized and perhaps including apreservative for the valve and perhaps including printed instructionsfor use. In other variations, the loading tool and crimping tool may beprovided separately, i.e., not attached to the stent-mounted valve.However, in the latter variation, the components may also be provided asa kit perhaps with separate or integrated packaging.

The crimping tool may have a converging-shape with an open, wide end anda narrower opposing end. The step of pulling the stent-mounted valvethrough the converging-shape crimping tool with the loading tool causesthe stent-mounted valve to become compressed, due to the decreasingdiameter of the crimping tool.

Once compressed, the stent-mounted valve (perhaps after a washing stepto remove preservative) may be loaded directly into the catheterdelivery tube for delivery using the transcatheter procedure. Theloading tool and stent may be configured so that the loading tool alsograsps the stent by switching from a larger diameter (or expanded state)to a compressed state as it is drawn through the crimping tool alongwith the stent-mounted valve.

The loading tool may then be attached to a control and delivery member,e.g., a inner shaft of a catheter delivery tube, and then both theloading tool and the stent-mounted valve are drawn into the catheterdelivery tube. This loading tool design greatly increases the ease oftransfer of the valve from the storage device to the catheter deliverytube. Also, with this loading tool, the valve is subjected to minimalhandling during transfer into the catheter delivery tube, a featurewhich assures the integrity of the valve itself.

As noted above, in one variation of the described component prongs, eachprong is provided with a notched end to engage a cooperative connectingmember or site located on, e.g., around the lower periphery of, thestent. In this variation, the diameter of the open connector, is largerthan the diameter of the open stent. As the prongs are slightlycompressed during attachment to the stent, the opening or notch in theend of the prong envelops a complementary connection on the stent tocreate and retain the connection with the stent.

In another variation, at least a portion of each of the prong isconstructed of a wire form. Each of the distal ends of the prongs isconfigured to engage a corresponding opening, e.g., an eye-hole, in acooperating connector located on the stent.

The loading tool may comprise one or more medically safe polymeric,metallic, or combination materials which preserve a high degree ofintegrity during the procedure. Suitable materials include metals oralloys such as many of the stainless steels, super-elastic alloys suchas NITINOL, titanium and titanium alloys, cobalt chromium alloys, andthe like. Suitable materials also include polymers such as many of theNylons, polycarbonates, polyimides, polyketones (such aspolyetheretherketone (PEEK), polyetherketoneketone (PEKK),polyetherketone (PEK), polyetherketoneetherketoneketone (PEKEKK), andpolyetheretherketoneketone (PEEKK), and generally apolyaryletheretherketone), and the like. Suitable polymeric materials,whether thermosets or thermoplastics, may be filled with, e.g., glassfibers, carbon fibers, polymeric fibers, ceramic fibers, and the like.The materials should be selected to have an elasticity allowing theloading tool to operate as described here.

The method of loading the stent mounted valve on the loading toolincludes, in one variation, slightly compressing the prongs of theloading tool, inserting the prongs within the bottom of thestent-mounted valve, aligning the prongs with the stent connectingmembers, releasing the prongs to allow outward movement towards thestent causing the stent to become fixed into place. In this manner, thestent-mounted valve becomes connected to the loading tool and may now bedrawn through the converging-shape crimping tool.

Once the stent is crimped, the loading tool is then coupled to acomponent of the delivery catheter assembly. The stent-mounted valve andthe loading tool are then drawn into the interior of the catheterdelivery tube, the converging-shape crimping tool is detached, and thestent-mounted valve and loading tool are retracted farther into thecatheter delivery tube in final preparation for the transcatheterprocedure.

When the stent-mounted valve is delivered during the transcatheterprocedure to the native heart valve, pushing the delivery tool slightlyforward within the catheter delivery tube, or holding the stent-mountedvalve in place as the catheter delivery tube is moved backward, willcause the stent-mounted valve to be exposed as it is released fromconstriction of the catheter delivery tube. The stent-mounted valve willthen self-expand into position in the native heart valve.

There is also described a system for loading a stent-mounted valve intoa catheter delivery tube for performance of a transcatheter valveimplantation procedure. The system may include a loading tool configuredto be removably connected to the stent of a stent-mounted valve. Theloading tool may be configured to be coupled to the inner shaft of acatheter delivery tube. The system may also comprise a crimping toolhaving a generally converging shape.

The loading tool may comprise a handle detachable from the loading toolafter the crimping of the stent-mounted valve is accomplished but priorto attachment of the loading tool to the catheter. By removing thehandle, the loading tool and the stent-mounted valve may then beretracted together into the catheter delivery tube.

The stent may be comprised of a wire assembly and formed with aplurality of connecting members for facilitating connection to theprongs of the loading tool. The connecting members may comprise a regionof the stent (e.g., when the stent is a wire-based structure or aspecific wire is added to a stent structure for the purpose ofconnecting to the loading tool) or may comprise members specificallyprovided to cooperatively attach to a prong. In one variation, theprongs each comprise a notch for facilitating connection to theconnecting members or regions of the stent. In other variations, theprongs each comprise a hook-shaped member for facilitating connection tothe stent

There is also described a method for withdrawing a stent-mounted valvefrom a storage container, crimping the stent-mounted valve, and loadingthe crimped stent-mounted valve into a catheter delivery tube for theperformance of a transcatheter valve implantation procedure. The methodincludes:

(a) providing a stent-mounted valve in a substantially open state insideof a storage container;

(b) providing a loading tool comprising at least one connector adaptedfor being removably connected to the stent-mounted valve, and furtheradapted for being coupled to a inner shaft of a catheter delivery tube;

(c) providing a generally converging-shape crimping tool;

(d) attaching the loading tool to the stout-mounted valve using the atleast one connector;

(e) withdrawing the stent-mounted valve from the storage container usingthe loading tool;

(f) pulling the stent-mounted valve through the crimping tool using theloading tool such that the stent-mounted valve becomes crimped;

(g) coupling the loading tool to the inner shaft of the catheterdelivery tube, and

(h) retracting the stent-mounted valve and the loading tool into thecatheter delivery tube.

Step (d) of the procedure may be performed by the stent-mounted valvemanufacturer. That step may comprise a step of providing a stent-mountedvalve, the connected loading tool, and the converging-shape crimpingtool inside of a storage container.

The procedure may include an additional step of washing thestent-mounted valve to remove traces of the storage medium.

The stent-mounted valve and the loading tool may be configured toautomatically disconnect or separate from each other upon release andexpansion of the stent-mounted valve within a native heart valveorifice.

Although the described device is described with reference to astent-mounted valve, the loading tool may be readily adapted for usewith any bio-prosthetic device which is switched from a substantiallyopen state to a substantially closed state in order to load into acatheter delivery tube.

The described loading tool need not be disconnected from thestent-mounted valve prior to delivery, as required by prior art toolsand methods. Instead, the loading tool itself becomes part of thedelivery system and facilitates the release of the stent-mounted valveout of the catheter delivery tube when the implantation site is reached.

Additional features and advantages of the described device will becomeapparent from the following drawings and description.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention with regard to theembodiments thereof, reference is made to the accompanying drawings, notto scale, in which like numerals designate corresponding elements orsections throughout, and in which:

FIG. 1 is a perspective view of the stent-mounted valve, where the stentis a wire-based structure;

FIG. 2 is an enlarged, perspective view of a three-pronged loading toolin its natural, expanded state;

FIG. 3 is an enlarged view of a three-pronged loading tool, shown in itscollapsed state;

FIG. 4 is a close-up, detailed view showing attachment of the loadingtool of FIGS. 2 and 3 to a self-expanding stent;

FIG. 5 is a close-up view of a portion of a self-expanding wire stentand a loading tool;

FIG. 6 is a schematic view, in partial cross-section, of a loading toolattached to a stent-mounted valve, a generally converging-shape crimpingtool, in wide-mouthed bottle storage packaging;

FIG. 7A is a partial cross-sectional view of a bottle storage packagingcontaining a stent-mounted valve;

FIG. 7B is a partial cross-sectional view of three-prong loading toolattached to the stent-mounted valve of FIG. 7A by the user;

FIG. 8 is a partial cross-sectional view illustrating the loading tooland stent-mounted valve of FIG. 6 after the stent-mounted valve and theloading tool have been crimped inside of the converging-shape crimpingtool;

FIG. 9 is a partial cross-sectional view illustrating the loading tooland stent-mounted valve of FIG. 6 after the handle has been detachedfrom the top of the loading tool;

FIG. 10 is a partial cross-sectional view illustrating the loading tooland stent-mounted valve of FIG. 6, after the catheter has been attachedto the upper end of loading tool;

FIG. 11 is a side view illustrating the loading tool and stent-mountedvalve of FIG. 6, after the loading tool and valve have been retractedinto the catheter delivery tube and the converging-shape crimping tubehas been removed; and

FIG. 12 is a schematic view illustrating the loading tool and thestent-mounted valve of FIG. 6, after the stent-mounted valve has beenreleased from the catheter delivery tube during the implantationprocedure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 is a perspective view of a self-expanding stent-mounted valve(20). Stent-mounted valve (20) may be of several types as is known tothose skilled in the art, but in the example of FIG. 1, thestent-mounted valve (20) is shown as a wire structure having awire-mesh, expandable frame stent (22). Engagement arms (25) aretypically configured to engage and/or rest against floors of aorticsinuses, to position the prosthetic valve assembly (20) in the nativevalve, and to apply an axial force directed towards the left ventricle.A more detailed description of our basic stent-mounted valve is providedin U.S. patent application Ser. No. 11/024,908, filed Dec. 30, 2004,published as No. 2006/0149360, to Schwammenthal, et al., hereinincorporated by reference in its entirety.

FIGS. 2 and 3 provide enlarged views of a three-prong loading tool (30)in an open state and in a closed state, respectively. The loading tool(30) has a base (32) and three prongs (34), extending therefrom forfacilitating connection to the stent-mounted valve using the notches(36) found at the prong tips. Three additional short prongs (35) extendfrom base (32) between prongs (34). Short prongs (35) serve to securethe positioning of loading tool (30) inside of a crimping tool, in amanner to be described further below. Base (32) is provided with apusher connector or base connectors (37) for coupling to a catheterassembly component, e.g., an inner shaft.

It is appreciated that prongs (34) in this variation should besufficiently flexible to allow the tips to be squeezed together (asshown in FIG. 3) and allow attachment to a stent-mounted valve. Theprongs (34) may have a comparatively stiff section adjacent the prongtips and a comparatively more flexible section, a hinge-like area,opposite the prong tips to allow the desired movement in attachment tothe stent. Alternatively, the desired flexibility of the prongs (34) maybe designed into the length of the prongs (34), i.e., each increment ofa prong bends in a similar amount, thereby eliminating the hinge area ofthe earlier discussed variation. Other variations of prong flexibility,e.g., variation of the prong flexibility from a higher value at the tipto a lower flexibility at the base, are also suitable. Otherwise, prongs(34) should be sufficiently rigid to allow them to form a portion of thecatheter delivery system.

In the variation illustrated, each prong (34) is provided with aradially outwardly facing notch (36) at its tip or distal end forconnection to the stent of a stent-mounted valve such as those shown inFIG. 1. Loading tool (30) may be formed from suitable, elastic,medically safe polymeric, metallic, or combination materials whichpreserve a high degree of integrity during the procedure. Specifically,unless breakage or deformation is desired as a component of a particulardesign, the materials should not otherwise break or become deformed whenin use. Suitable materials include metals or alloys such as many of thestainless steels, super-elastic alloys such as nitinol, titanium andtitanium alloys, cobalt chromium alloys, and the like. Suitablematerials also include polymers such as many of the Nylons,polycarbonates, polyimides, polyketones (such as polyetheretherketone(PEEK), polyetherketoneketone (PEKK), polyetherketone (PEK),polyetherketoneetherketoneketone (PEKEKK), andpolyetheretherketoneketone (PEEKK), and generally apolyaryletheretherketone), and the like. Suitable polymeric materials,whether thermosets or thermoplastics, may be filled with, e.g., glassfibers, carbon fibers, polymeric fibers, ceramic fibers, and the like.

The design specifics of the loading tool (30) may be altered from thoseillustrated in the drawings for connecting to the stent (22), so long asthe function of the tool is preserved. For instance, in the variationshown in FIGS. 2 and 3, the loading tool (32) includes prongs (34) withnotches (36) that open outwardly, the prongs switching from an openstate allowing attachment to the stent, to a closed state, allowingloading into the catheter delivery tube. With appropriate modification,the notches may, however, open inwardly or be open at the end of theprongs. However, a suitable loading tool is simply one having aconnector or connector region permitting controllable connection to thestent, facilitating compression (or crimping) of the stent-mountedvalve, loading of the stent-mounted valve into a catheter delivery tube,and controllably releasing the stent-supported valve at the deliverysite.

As mentioned above, the depicted loading tool (30) includes three prongs(34). This number of prongs (34) may be chosen as a balance betweenproviding adequate support of the stent during the crimping step andproviding the minimum number of suitably functional mechanicalcomponents. Of course, this variation of the loading tool may includeany other suitable number of prongs such as, but not limited to, two,four, five or six. In each case, the stent-mounted valve would typicallybe provided with a corresponding number of connecting members (orconnecting regions) in the stent to allow cooperative connectiontherebetween. For example, in variations where the loading tool hasthree prongs, the stent generally would also have three prongs. However,the stent may be designed to include more than three connection members,sites, or regions to ease the step of connection between the loadingtool and the stent by providing additional connection sites.

FIG. 4 is an enlarged, detailed view showing the connection of theloading tool of FIGS. 2 and 3 to a stent-mounted valve. Notch (36) ofprong (34) connects to the stent connector (26) of stent (22) in themanner illustrated, with connector (26) seated inside of notch (36). Thestent connector (26) radially slides into notch (36). However, the notch(36) is configured so that the stent connector (26) does notsubstantially move axially in either direction. This configuration meansthat the connection is firm whether the loading tool is being used topull the stent-mounted valve through the crimping tool or to push thecrimped stent-mounted valve through the delivery catheter.

The loading tool (30) has a longitudinal axis and the at least oneconnector, in this case, comprising the prong(s) (34) is configured toremovably attach to the stent (22) of the stent valve (20).

The depicted stent connector (26) includes an aperture (38) that is notnecessary for the connection shown in FIG. 4, but may be used inconjunction with other prong variations, such as that shown in FIG. 5.

FIG. 5 is an enlarged, detailed view of an alternative connecting prong(34). In this variation, the prong (34) is provided with a hook member(42) at its distal end. The distal tip of the hook (42) passes throughthe aperture (38) in the stent connector (26). As is the case with prongvariation discussed with regard to FIG. 3, the distal tip of the hook(42) prevents substantial, axial movement between the stent and theloading tool, but allows radial movement between the prong (34) and thestent-mounted valve during engagement and implantation of the valve.

The connection between the stent and the loading tool allows for thestent-mounted valve to be crimped and easily loaded into a catheterdelivery tube, together with the loading tool. The depicted loadingtools employ prongs having outward-facing notches. This means that theloading tool is placed inside the stent and the prongs grasp the stentfrom its interior. For those variations using a self-expanding stent,delivery of the stent-mounted valve allows the stent to undergoself-expansion. The stent expands away from the loading tool. This couldbe characterized as automatic disconnection of the stent from theloading tool.

FIG. 6 shows a partial cross-section of an assembly useful as aself-contained kit suitable for commercial delivery to a surgical user,e.g., a hospital, clinic, surgical suite, physician, etc. In addition tothe assembly described below, additional exterior packaging and writteninstructions may be included as necessary or appropriate. In any case,the assembly comprises a loading tool (30) attached to (or attachableto) a stent-mounted valve (20). A generally converging-shape (orconverging diameter) crimping tool (48) substantially surrounds theloading tool (30) and valve (20). These components are all includedwithin a wide-mouthed bottle storage container (50) serving as packagingfor the assembly. The crimping tool (48) may have any suitable hollow,generally converging shape that compresses the stent-mounted valve (20)as it moves through the interior of the crimping tool (48).

Stent-mounted valve (20) is shown as sitting at the bottom of bottlestorage container (50). In the example illustrated, three-prong loadingtool (30) is attached to stent (22) of stent-mounted valve (20), by acooperative connection in which the stent connector (26) slides radiallyinto notch (36) of prong (34) of loading tool (30), as shown in FIG. 4.Stent-mounted valve (20) and attached loading tool (30) are situatedwithin converging-shape crimping tool (48). Bottle delivery or storagecontainer (50) is filled with a sterile, non-volatile preservative, afluid, commonly glutaraldehyde. The glutaraldehyde should be washed fromthe crimped components after their removal from the delivery and storagecontainer (50).

After any exterior packaging and the top (54) are removed from storagecontainer (50), a user (even a user wearing sterile disposable gloves)can easily remove the components from the storage container (50) bygripping the crimping tool (48) and handle (56). The handle (56) isremovably connected to loading tool (30). Pulling handle (56) withrespect to the crimping tool (48) draws the stent-mounted valve (20) andloading tool (30) upwards through that converging-shape crimping tool(48). The action crimps stent-mounted valve (20) and compresses prongs(34, 35) of loading tool (30) as these components pass into and throughthe narrow neck (52) of converging-shape crimping tool (48).

FIGS. 7A and 7B show alternative delivery packaging for thestent-mounted valve (20). In this variation, loading tool (30) and theconverging-shape crimping tool (48) are provided separately from thestent-mounted valve (20). In this variation, the stent-mounted valve(20) is enclosed in closed packaging storage container (50) havingclosure or lid (54). The storage container (54) is typically filled witha liquid, e.g., comprising a preservative such as glutaraldehyde. Theexemplified stent-mounted valve (20) is shown having stent (22) withstrut supports (24). A base (60) may be provided in the storagecontainer (50) for supporting stent-mounted valve (20) in the liquidmedium.

The various disclosed devices and combinations are also useful for othertypes of expandable stents, stent/valve combinations, and expandableprosthetics that are to be collapsed for delivery, delivered via atranscatheter procedure, and expanded at or before delivery.

In the variation shown in FIGS. 7A and 7B, to remove the stent-mountedvalve (20) from the packaging, the user first removes cover (54) fromstorage container (50). The user then grasps loading tool (30) andslightly compresses prongs (34) inward and aligns the notches (36) ofprongs (34) with the corresponding stent connectors (26) or regions ofstent (22) such that when the prongs (34) are released in a controlledmanner, stent (22) becomes connected to loading tool (30), as seen inFIG. 7B.

As noted above, prior to loading into the catheter delivery tube, thestent-mounted valve (20) may be washed to remove the preservative.

FIG. 8-11 show the operation of the components, particularly the loadingtool (30), stent-mounted valve (20), and converging-shape crimping tool(48), as they are taken from the integrated packaging (shown in FIG. 6)and placed in the catheter housing, and a the valve is implanted in theheart.

FIG. 8 is a schematic view illustrating the loading tool (30) andstent-mounted valve (20) after they have been removed from the packaging(50) of FIG. 6 and after the stent-mounted valve (20) and the loadingtool (30) have been, respectively, crimped and collapsed inside of theconverging-shape crimping tool (48). The crimping of stent-mounted valve(20) and the collapsing of the prongs (34) of loading tool (30) areaccomplished by pulling upwardly on handle (56). Handle (56) draws thosecomponents up and through converging-shape crimping tool (48) causingthe prongs (34) of loading tool (30) to switch from an open to a closedconfiguration while remaining connected to stent-mounted valve (20).

Handle (56) is removably attached to loading tool (30) perhaps via aquick-release type mechanical coupling (64). However, other suitablecoupler designs may be employed for removably connecting handle (56) toloading tool (30). A two-position sliding clasp (65) or stopper isprovided on the top of crimping tool (48). The sliding clasp (65) isshaped such that when in a first open position, handle (56) may bepulled upward. When the sliding clasp (65) is slid to a second (orclosed) position, the sliding clasp (65) blocks upward movement ofhandle (56). Thus, following crimping of stent-mounted valve (20) bypulling it up into the neck (52) of crimping tool (48), the user slidessliding clasp (65) to the closed position and so prevents stent-mountedvalve (20) and loading tool (30) from being prematurely released fromcrimping tool (48).

FIG. 8 also shows a circumferential indentation (57) in neck (52). Thisindentation (57) serves as a “safety stop,” in the sense that itprevents the stent-mounted valve (20) from retracting into the largerdiameter section of the crimping tool (48) after it has been pulled intothe narrow neck (52). Specifically, as loading tool (30) andstent-mounted valve (20) are drawn upward through crimping tool (48),short prongs (35) of loading tool (30) engage indentation (57). Thisserves to prevent the stent-mounted valve (20) from descending into thecrimping tool (48), particularly after the handle (56) is removed, andto thereby prevent unwanted re-opening of stent-mounted valve (20). Insum, sliding clasp (65) prevents upward movement of loading tool (30)and valve (20); indentation (57) and short prongs (35) prevent downwardmovement of loading tool (30) and valve (20).

As is shown in FIG. 9, handle (56) is detached from loading tool (30)following crimping of stent-mounted valve (20) and loading tool (30) andsubsequent closing of sliding clasp (65).

As illustrated in FIG. 10, loading tool (30) is then attached to adelivery catheter (66). comprising a catheter delivery tube (68) and aninner shaft (70) that extends coaxially through the interior of catheterdelivery tube (68) to the loading tool (30). A mechanical coupling (64)connects the pusher or base connector (37) of loading tool (30) to innershaft (70) of delivery catheter (66). Inner shaft (70) has the dualfunction of pulling the loading tool (30)/valve (20) into the cathetertube (68) and pushing the valve (20) out of the catheter tube (68) atimplantation due to the relative motion between the inner shaft and thedelivery tube. Said another way: backward movement of shaft (70)relative to the catheter delivery tube (68) causes loading tool (30) andstent-mounted valve (20) to be drawn out of crimping tool (48) and intocatheter delivery tube (68). The loading tool (30) and stent-mountedvalve (20) remain crimped or collapsed after entering the catheterdelivery tube (68). The crimping tool (48) is then released and may bediscarded. At this juncture, loading tool (30) and stent-mounted valve(20) are then retracted further into delivery catheter (66) by shaft(70). The assembly is then ready for passage through another catheter(or “outer tube”) to the implantation site in the heart.

In FIG. 11, engagement arms (25) are shown to be external to cathetertube (68) during the passage of the stent-mounted valve (20) to thedelivery site. During implantation, the delivery catheter (66) isadvanced over a guidewire until the distal tip of the stent-mountedvalve (20) and the engagement arms (25) pass through the native aorticvalve. The delivery catheter (66) is then slightly withdrawn to flarethe engagement arms (25) laterally into the valve sinuses. At thispoint, the stent is still in a compressed state in the catheter deliverytube (68).

Subsequent retraction of the catheter delivery tube (68), whilemaintaining the stent-mounted valve (20) stationary using the Innershaft (70), causes release of stent-mounted valve (20) and its placementand opening within the native heart valve orifice. The releasing andopening of the stent-mounted valve (20) causes the stent (22) to expandaway from and be automatically disconnected from the still-compressedloading tool (30), as seen in FIG. 12. As mentioned above, the prongs(34) of the loading tool (30) reside in the interior of the stent (22),and when the stent (22) opens, the stent connectors readily exit thenotches (36) formed in the prongs (34) of the loading tool (30).

Having described the invention with regard to certain specificembodiments thereof, it is to be understood that the description is notmeant as a limitation, since further modifications may now suggestthemselves to those skilled in the art, and it is intended to cover suchmodifications as fall within the scope of the appended claims.

We claim:
 1. A method for withdrawing, crimping, and loading astent-mounted valve from a storage container into a delivery catheterfor the performance of a transcatheter valve implantation procedure, themethod comprising: attaching a loading tool to a substantially openstate stent-mounted valve inside a storage container using a connectorof the loading tool in an open state, wherein the connector isconfigured to be removably connected to the stent-mounted valve, andwherein the loading tool is configured to be coupled to an inner shaftof a delivery catheter; withdrawing the stent-mounted valve from thestorage container using the loading tool; advancing the stent-mountedvalve and the connector of the loading tool through a generallyconverging-shape crimping tool using the loading tool such that thestent-mounted valve becomes crimped and the connector of the loadingtool radially contracts from the open state to a closed state; couplingthe loading tool to the inner shaft of the delivery catheter; andretracting the stent-mounted valve and the loading tool into thedelivery catheter.
 2. The method of claim 1, wherein during theattaching the loading tool to the substantially open state stent-mountedvalve, the stent-mounted valve is inside the converging-shape crimpingtool, and the converging-shape crimping tool is inside the storagecontainer.
 3. The method of claim 1, further comprising washing thestent-mounted valve.
 4. The method of claim 1, wherein the stent-mountedvalve is configured to be automatically disconnected from the loadingtool upon release and expansion of the stent-mounted valve within anative heart valve orifice.
 5. The method of claim 1, wherein theconnector comprises a prong.
 6. The method of claim 1, wherein theconnector comprises three prongs.
 7. The method of claim 1, wherein theloading tool further comprises a detachable handle configured to bedetached from the loading tool after crimping of the stent-mountedvalve, and before coupling of the loading tool to the delivery catheter.8. The method of claim 1, wherein the connector comprises a plurality ofprongs, wherein in the open state distal ends of the plurality of prongsare spread apart from each other, and when the connector is advancedthrough the generally converging-shape crimping tool the distal ends ofthe plurality of prongs move towards each other.
 9. The method of claim8, wherein each of the plurality of prongs includes a radially outwardlyfacing notch, and wherein the step of attaching the loading tool to thestent-mounted valve comprises inserting stent connectors of thestent-mounted valve into each radially outwardly facing notch.
 10. Themethod of claim 8, wherein each of the plurality of prongs includes aradially outwardly facing hook member, and wherein the stent-mountedvalve includes a plurality of stent connectors with each stent connectorincluding an aperture, and wherein the step of attaching the loadingtool to the stent-mounted valve comprises inserting each hook memberinto a corresponding aperture of one of the plurality of stentconnectors.
 11. The method of claim 1, wherein the connector comprises aplurality of long prongs, wherein in the open state distal ends of theplurality of long prongs are spread apart from each other, wherein whenthe connector is advanced through the generally converging-shapecrimping tool the distal ends of the plurality of long prongs movetowards each other, wherein the loading tool comprises at least oneshort prong, wherein a narrow neck of the crimping tool includes atleast an indentation, and wherein when the loading tool is advancedthrough the crimping tool such that the at least one short prong isproximal of the indentation, interaction of the at least one short prongand the indentation prevents the loading tool from being advanceddistally.
 12. A method for withdrawing, crimping, and loading astent-mounted valve from a storage container into a delivery catheterfor the performance of a transcatheter valve implantation procedure, themethod comprising: removably attaching a loading tool to a portion of astent-mounted valve inside a storage container using a connector of theloading tool, wherein the stent-mounted valve including the portion towhich the connector is removably attached is in a radially expandedconfiguration, withdrawing the stent-mounted valve from the storagecontainer using the loading tool; advancing the stent-mounted valvethrough a generally converging-shape crimping tool using the loadingtool such that the stent-mounted valve including the portion to whichthe connector is removably attached compresses into a radially collapsedconfiguration; coupling the loading tool to an inner shaft of thedelivery catheter; and retracting the stent-mounted valve and theloading tool into the delivery catheter.
 13. The method of claim 12,wherein the stent-mounted valve is configured to be automaticallydisconnected from the loading tool upon release and expansion of thestent-mounted valve within a native heart valve orifice.
 14. The methodof claim 12, wherein the connector comprises a prong.
 15. The method ofclaim 12, wherein the connector comprises three prongs.
 16. The methodof claim 12, wherein the loading tool further comprises a detachablehandle configured to be detached from the loading tool after crimping ofthe stent-mounted valve, and before coupling of the loading tool to thedelivery catheter.
 17. The method of claim 12, wherein the connectorcomprises a plurality of prongs, wherein the plurality of prongs are inan open state when the loading tool is removably attached to the portionof the stent-mounted valve, and wherein when stent-mounted valve isadvanced through the generally converging-shape crimping tool theplurality of prongs move towards each other to a closed state.
 18. Themethod of claim 17, wherein each of the plurality of prongs includes aradially outwardly facing notch, and wherein the step of removablyattaching the loading tool to the stent-mounted valve comprisesinserting stent connectors of the stent-mounted valve into each radiallyoutwardly facing notch.
 19. The method of claim 17, wherein each of theplurality of prongs includes a radially outwardly facing hook member,and wherein the stent-mounted valve includes a plurality of stentconnectors with each stent connector including an aperture, and whereinthe step of removable attaching the loading tool to the stent-mountedvalve comprises inserting each hook member into a corresponding apertureof one of the plurality of stent connectors.